Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment (DRESSING2)

October 18, 2013 updated by: University Hospital, Grenoble

Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study

Catheter related infection is a frequent and life threatening event in ICU. A chlorhexidine impregnated sponge has been proven to reduce the rate of major catheter related infections in ICU patients (HR=0.39, p=0.03) (Timsit Jama 2009). However, dressings are detached in 40% of cases before planned changes and the rate of unplanned dressing is significantly associated with the major catheter related infections.

Primary objective: To demonstrate that Tegaderm CHG, a new CHG impregnated dressing decrease the rate of major catheter related infection as compared to non impregnated dressings and to demonstrate that highly adhesive dressing decrease the rate of detached dressings.

Secondary objectives:

  • To demonstrate that the use of high performance dressing decrease the rate of unstuck dressing and the rate of catheter infections.
  • To evaluate the tolerance of CHG impregnated gel dressings (Tegaderm CHG).
  • To calculate the cost saving of each dressings

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria: Patients older than 18 years old with central venous who need a central vein and/or an arterial catheter for an expected duration of more than 48 hours.

Study Type

Interventional

Enrollment (Actual)

1960

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients older than 18 years old with a central venous catheter or arterial catheter installed in the study departement for a maximum for 24 hours

Exclusion Criteria:

  • pulmonary arterial catheter
  • antiseptic-impregnated catheter
  • hemodialysis catheter
  • chlorhexidine allergy
  • emergency catheter without surgical asepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tegaderm HP
Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG
Placebo Comparator: Tegaderm
Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG
Active Comparator: Tegaderm CHG
Procedure: Tegaderm, Tegaderm HP, Tegaderm CHG
dressings on catheters
Other Names:
  • Tegaderm
  • Tegaderm HP
  • tegaderm CHG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
Time Frame: 48 hours after catheter removal or ICU discharge (10 days on average)
The patients were followed 48h after catheter removal or discharge. Average follow up of 10 days.
48 hours after catheter removal or ICU discharge (10 days on average)

Secondary Outcome Measures

Outcome Measure
Time Frame
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
Time Frame: until catheter removal or ICU discharge (8 days on average)
until catheter removal or ICU discharge (8 days on average)
Comparison of Group 1 to group 2+3 : catheter colonization, CR-BSI, cutaneous colonization at catheter removal, cost
Time Frame: 48 hours after catheter removal or ICU discharge (10 days on average)
48 hours after catheter removal or ICU discharge (10 days on average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: TIMSIT Jean-François, PU/PH, Unit intensive care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A01184-53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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